510(k) K964946

SYSMEX CA-1000/SYSMEX CA-5000 by Sysmex Corp. — Product Code JPA

K964946 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "SYSMEX CA-1000/SYSMEX CA-5000". The FDA issued a decision of Substantially Equivalent on March 18, 1997. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Sysmex Corp. has at least 10 other 510(k) clearances on record.